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Brainomix 360 e-ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data.

The software automatically registers images and uses an atlas to segment and analyze ASPECTS regions. Brainomix 360 e-ASPECTS extracts image data from individual voxels in the image to provide analysis and computer analytics and relates the analysis to the atlas defined ASPECTS regions. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECTS (Alberta Stroke Program Early CT) score.

Brainomix 360 e-ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score. Brainomix 360 e-ASPECTS provides information that may be useful in the characterization of ischemic brain tissue injury during image interpretation (within 24 hours from time last known well).

Brainomix 360 e-ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment by providing highlighted ASPECTS regions and an automated editable ASPECTS score for clinician review. Brainomix 360 e-ASPECTS additionally provides a visualization of the voxels contributing to and excluded from the automated ASPECTS score, and a calculation of the voxel volume contributing to ASPECTS score.

Limitations:

1. Brainomix 360 e-ASPECTS is not intended for primary interpretation of CT images. It is used to assist physician evaluation.
2. The Brainomix 360 e-ASPECTS score should be only used for ischemic stroke patients following the standard of care.
3. Brainomix 360 e-ASPECTS has only been validated and is intended to be used in patient populations aged over 21 years.
4. Brainomix 360 e-ASPECTS is not intended for mobile diagnostic use. Images viewed on a mobile platform are compressed preview images and not for diagnostic interpretation.
5. Brainomix 360 e-ASPECTS has been validated and is intended to be used on Siemens Somatom Definition scanners.

Contraindications/ Exclusions/Cautions:

· Patient motion: Excessive patient motion leading to artifacts that make the scan technically inadequate.
· Hemorrhagic Transformation, Hematoma.

Brainomix 360 e-ASPECTS (also referred to as e-ASPECTS in this submission) is a medical image visualization and processing software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server.

Brainomix 360 e-ASPECTS allows for the visualization, analysis and post-processing of DICOM compliant Non-contrast CT (NCCT) images which, when interpreted by a trained physician or medical technician, may yield information useful in clinical decision making.

Brainomix 360 e-ASPECTS is a stand-alone software device which uses machine learning algorithms to automatically process NCCT brain image data to provide an output ASPECTS score based on the Alberta Stroke Program Early CT Score (ASPECTS) guidelines.

The post-processing image results and ASPECTS score are identified based on regional imaging features and overlayed onto brain scan images. e-ASPECTS provides an automatic ASPECTS score based on the input CT data for the physician. The score includes which ASPECTS regions are identified based on regional imaging features derived from NCCT brain image data. The results are generated based on the Alberta Stroke Program Early CT Score (ASPECTS) guidelines and provided to the clinician for review and verification. At the discretion of the clinician, the scores may be adjusted based on the clinician's judgment.

Brainomix 360 e-ASPECTS can connect with other DICOM-compliant devices, for example to transfer NCCT scans from a Picture Archiving and Communication System (PACS) to Brainomix 360 e-ASPECTS software for processing.

Results and images can be sent to a PACS via DICOM transfer and can be viewed on a PACS workstation or via a web user interface on any machine contained and accessed within a hospital network and firewall and with a connection to the Brainomix 360 e-ASPECTS software (e.g. a LAN connection).

Brainomix 360 e-ASPECTS notification capabilities enable clinicians to preview images through a mobile application or via e-mail.

Brainomix 360 e-ASPECTS email notification capabilities enable clinicians to preview images via e-mail notification with result image attachments. Images that are previewed via e-mail are compressed, are for informational purposes only, and not intended for diagnostic use beyond notification.

Brainomix 360 e-ASPECTS is not intended for mobile diagnostic use. Notified clinicians are responsible for viewing non-compressed images on a diagnostic viewer and engaging in appropriate patient evaluation and relevant discussion with a treating physician before making care-related decisions or requests.

Brainomix 360 e-ASPECTS provides an automated workflow which will automatically process image data received by the system in accordance with pre-configured user DICOM routing preferences.

Once received, image processing is automatically applied. Once any image processing has been completed, notifications are sent to pre-configured users to inform that the image processing results are ready. Users can then access and review the results and images via the web user interface case viewer or PACS viewer.

The core of e-ASPECTS algorithm (excluding image loading or result output format) can be summarised in the following 3 key steps of the processing pipeline:

• Pre-processing: brain extraction from the three dimensional (3D) non-enhanced contrast CT head dataset and its reorientation/normalization by 3D spatial registration to a standard template space.
• Delineation of the 20 (10 for each cerebral hemisphere) pre-defined ASPECTS regions of interest on the normalized 3D image.
• Image feature extraction and heatmap generation which consists of the computation of numerical values characterizing brain tissue, apply a trained predictive model to those features and generate a 3D heatmap from the models output for highlighting regions contributing towards the ASPECTS score.

The Brainomix 360 e-ASPECTS module is made available to the user through the Brainomix 360 platform. The Brainomix 360 platform is a central control unit which coordinates the execution image processing modules which support various analysis methods used in clinical practice today:

• Brainomix 360 e-ASPECTS (K221564) (predicate device)
• Brainomix 360 e-CTA (K192692)
• Brainomix 360 e-CTP (K223555)
• Brainomix 360 e-MRI (K231656)
• Brainomix 360 Triage ICH (K231195)
• Brainomix 360 Triage LVO (K231837)
• Brainomix 360 Triage Stroke (K232496)

Here's a breakdown of the acceptance criteria and the study proving the device's performance, based on the provided text:

Brainomix 360 e-ASPECTS Device Performance Study

The Brainomix 360 e-ASPECTS device underwent performance testing to demonstrate its accuracy and effectiveness. This included both standalone algorithm performance and a multi-reader multi-case (MRMC) study to assess the impact of AI assistance on human readers.

1. Acceptance Criteria and Reported Device Performance

Digital Phantom Validation (for "volume contributing to e-ASPECTS")

Standalone Performance Testing (for ASPECTS score accuracy)

Multi-Reader Multi-Case (MRMC) Study (Human + AI vs. Human only for ASPECTS score accuracy)

2. Sample Sizes and Data Provenance

• Digital Phantom Validation Test Set: n=110 synthetic datasets
• Standalone Performance Test Set: n=137 non-contrast CT scans
  • Data Provenance: From 3 different USA institutions (Siemens, GE, Philips, and Toshiba scanners).
  • Retrospective/Prospective: The data appears to be retrospective based on the description of patient admission dates (March 2012 and August 2023) and clinical context.
• MRMC Study Test Set: n=140 NCCT scans
  • Data Provenance: Cases collected from various clinical sites (specific countries not explicitly stated, but the mention of US neuroradiologists for ground truth suggests US data). Scanners included Siemens, GE, Philips, and Toshiba.
  • Retrospective/Prospective: The study used "retrospective data" (explicitly stated on page 12).
• Training Set Sample Size: The document does not specify the sample size for the training set. It mentions the algorithm is based on "machine learning" and a "trained predictive model" but provides no details on the training data.

3. Number of Experts and Qualifications for Ground Truth Establishment

• Standalone Performance Test Set: Three board-certified US neuroradiologists. No information on years of experience is provided.
• MRMC Study Test Set: Three board-certified US neuroradiologists for establishing the ground truth that human readers were compared against. No information on years of experience is provided.

4. Adjudication Method for the Test Set(s) Ground Truth

• Standalone Performance Test Set: "Consensus of three board-certified US neuroradiologists." This implies that the ground truth was established by agreement among the three experts. The specific method (e.g., 2-out-of-3, or discussion to reach full consensus) is not detailed, but "consensus" suggests agreement.
• MRMC Study Test Set: "Consensus of three board-certified US neuroradiologists." Similar to the standalone study, ground truth was established by consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was it done?: Yes, an MRMC study was conducted.
• Effect Size: The study showed a 6.4% improvement in AUC for readers with e-ASPECTS support (85%) compared to without e-ASPECTS support (78%). This improvement was statistically significant (p=.03). There was also an improvement in sensitivity (from 61% to 72%) and a small improvement in specificity (from 96% to 98%). Cohen's Kappa and weighted Kappa also improved significantly.
• Readers: 7 clinical readers (1 "expert" neuroradiologist and 6 "non-expert" radiologists or neurologists).

6. Standalone Performance (Algorithm Only)

• Was it done?: Yes, a standalone performance testing was conducted.
• Performance Metrics: The algorithm achieved an AUC of 83% (95% CI: 80-86%), with a sensitivity of 69% (56-75%) and a specificity of 97% (80-97%) on a case-level as compared to expert consensus. Area under the curve (AUC) specifically refers to overall region-level performance.

7. Type of Ground Truth Used

• Digital Phantom Validation: Synthetic volumes/known phantom volumes.
• Standalone Performance Testing: Expert consensus (of three board-certified US neuroradiologists).
• MRMC Study: Expert consensus (of three board-certified US neuroradiologists).

8. Sample Size for the Training Set

The document does not provide a specific sample size for the training set. It only states that the device uses "machine learning algorithms" and a "trained predictive model."

9. How Ground Truth for Training Set Was Established

The document does not describe how the ground truth for the training set was established. It only refers to a "trained predictive model."

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Brainomix 360 e-ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data.

The software automatically registers images and uses an Atlas to segment and analyze ASPECTS regions. Brainomix 360 e-ASPECTS extracts image data from individual voxels in the image to provide analysis and computer and relates the analysis to the atlas defined ASPECTS regions. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECTS (Alberta Stroke Program Early CT) Score.

Brainomix 360 e-ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup with known MCA or ICA occlusion, for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score. Brainomix 360 e-ASPECTS provides information that may be useful in the characterization of ischemic brain tissue injury during image interpretation (within 6 hours from time last known well).

Brainomix 360 e-ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment by providing highlighted ASPECTS regions and an automated editable ASPECTS score for clinician review. Brainomix 360 e-ASPECTS additionally provides a visualization of the voxels contributing to the automated ASPECTS score and the voxels excluded from the automated ASPECTS score.

Limitations:

1. Brainomix 360 e-ASPECTS is not intended for primary interpretation of CT images. It is used to assist physician evaluation.

2. Brainomix 360 e-ASPECTS has been validated in patients with known MCA or ICA occlusion prior to ASPECTS scoring.

3. Brainomix 360 e-ASPECTS is not suitable for use on brain scans displaying neurological pathologies other than acute stroke, such as tumours or abscesses, haemorrhagic transformation and hematoma.

4. Use of Brainomix 360 e-ASPECTS Module in clinical settings other than brain ischemia within 6 hours from time last known well, caused by known ICA or MCA occlusions has not been tested.

5. Brainomix 360 e-ASPECTS has only been validated and is intended to be used in patient populations aged over 21.

6. Brainomix 360 e-ASPECTS has been validated and is intended to be used on Siemens Somatom Definition scanners.

7. Brainomix 360 e-ASPECTS is not intended for mobile diagnostic use. Images viewed on a mobile platform are compressed preview images and not for diagnostic interpretation.

Contraindications/Exclusions/Cautions:

· Patient motion: Excessive patient motion leading to artifacts that make the scan technically inadequate.

• · Haemorrhagic Transformation, Hematoma.

Brainomix 360 e-ASPECTS is a stand-alone software device which uses machine learning algorithms to automatically process NCCT (Non-contrast CT scans) brain image data to provide an output ASPECTS score based on the Alberta Stroke Program Early CT Score (ASPECTS) guidelines.

The post-processing image results and ASPECTS score are identified based on regional imaging features and overlayed onto brain scan images. e-ASPECTS provides an automatic ASPECTS score based on the input CT data for the physician. The score includes which ASPECTS regions are identified based on regional imaging features derived from non-contrast computed tomography (NCCT) brain image data. The results are generated based on the Alberta Stroke Program Early CT Score (ASPECTS) guidelines and provided to the clinician for review and verification. At the discretion of the clinician, the scores may be adjusted based on the clinician's judgment.

Brainomix 360 e-ASPECTS can connect with other DICOM-compliant devices, for example to transfer NCCT scans from a Picture Archiving and Communication System (PACS) to Brainomix 360 e-ASPECTS software for processing.

Results and images can be sent to a PACS via DICOM transfer and can be viewed on a PACS workstation or via a web user interface on any machine contained and accessed within a hospital network and firewall and with a connection to the Brainomix 360° e-ASPECTS software (e.g. a LAN connection)

Brainomix 360 e-ASPECTS notification capabilities enable clinicians to preview images through via email notification with result image attachments.

lmages that are previewed via e-mail are compressed, are for preview purposes only, and not intended for diagnostic use beyond notification.

Brainomix 360 e-ASPECTS is not intended for mobile diagnostic use. Notified clinicians are responsible for viewing non-compressed images on a diagnostic viewer and engaging in appropriate patient evaluation and relevant discussion with a treating physician before making care-related decisions or requests.

Brainomix 360 e-ASPECTS provides an automated workflow which will automatically process image data received by the system in accordance with pre-configured user DICOM routing preferences.

Once received, image processing is automatically applied. Once any image processing has completed, notifications are sent to pre-configured users to inform that the image processing results are ready. User can then access and review the results and images via the Web User Interface case viewer or PACS viewer.

Brainomix 360 e-ASPECTS principal workflow for NCCT includes the following key steps:

• NCCT Image Loading.
• . Automated image analysis and processing to identify and visualize the voxels which have been included in the ASPECTS score and the voxels which have been excluded from the ASPECTS score (Also referred to as a 'heat map').
• Automated image analysis and processing to register the subject image to an atlas to segment and highlight ASPECTS regions and to display whether or not each region is qualified as contributing to the ASPECTS score.
• . Notifications and alerts to users.
• Generation of a summary results report.
• Presentation of results for review and analysis by users.

Once the physician has been notified of availability of the ASPECTS score, the system requires that the physician confirms that the case in question is for an ICA occlusion. The ASPECTS results, including the ASPECTS score, indication of affected side, affected ASPECTS regions and voxel-wise analysis (shown as a heatmap of voxels 'contributing to e-ASPECTS score' and a heat map of voxels 'excluded from e-ASPECTS score') can be exported as a report and/or sent to the Picture Archiving and Communications System (PACS).

Here's a summary of the acceptance criteria and the study that proves the Brainomix 360 e-ASPECTS device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a separate table in the provided text. However, the "Stand-alone Performance Testing" and "Clinical Studies" sections describe performance metrics that were evaluated. I will infer the acceptance criteria from the reported performance which was deemed sufficient for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Stand-alone Performance Test Set:
  • Sample Size: 256 non-contrast CT scans.
  • Data Provenance: Retrospective data from 8 different USA institutions. Patients were admitted between March 2014 and March 2020.
• MRMC Clinical Study Test Set:
  • Sample Size: 54 clinically representative NCCT retrospective scans.
  • Data Provenance: Retrospective data. While not explicitly stated, the context of clinical studies for FDA clearance typically implies multi-center or diverse data sources to demonstrate generalizability, but the exact origin (e.g., country) beyond "retrospective" for this specific set is not detailed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Stand-alone Performance Test Set: The text states "Ground truth ASPECTS score was 6 in 213 patients." but it does not explicitly state the number of experts or their qualifications used to establish this ground truth. However, the subsequent MRMC study provides this detail about its ground truth.
• MRMC Clinical Study Test Set:
  • Number of Experts: Three expert neuroradiologists.
  • Qualifications: "expert neuroradiologists with access to clinical data and follow up imaging." (Further details on years of experience are not provided.)

4. Adjudication Method for the Test Set

• Stand-alone Performance Test Set: The adjudication method for the ground truth is not explicitly stated.
• MRMC Clinical Study Test Set: The ground truth was established by "three expert neuroradiologists with access to clinical data and follow up imaging." This suggests a consensus-based approach, but the specific adjudication rules (e.g., majority vote, discussion to agreement) are not detailed (e.g., 2+1, 3+1 rule).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• Yes, a MRMC cross-over study was conducted.
• Effect Size:
  • The primary endpoint showed a statistically significant improvement of 0.02 in AUC (from 0.81 to 0.83, p=0.028) when readers were assisted by Brainomix 360 e-ASPECTS compared to unassisted reading.
  • This was driven by an increase in sensitivity (positive percentage agreement) from 66% to 70% and a small improvement in specificity (negative percentage agreement) to 96%.
  • Overall accuracy improved from 93% to 94%.
  • The study also noted that greater magnitude of AUC increases were observed in "lower performers," and the range in AUC between users was narrower with e-ASPECTS, indicating a reduction in variability.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Yes, "Stand-alone Performance Testing" was conducted to comply with special controls for this device type. This tested the algorithm's performance directly against ground truth, independent of human readers.

7. The Type of Ground Truth Used

• Stand-alone Performance Test Set: The ground truth was based on "available follow up imaging at 24 hours." This indicates outcomes data or established pathology from follow-up scans (e.g., evolution of infarct on follow-up imaging serving as ground truth for early ischemic changes).
• MRMC Clinical Study Test Set: The ground truth was established by "three expert neuroradiologists with access to clinical data and follow up imaging." This indicates a combination of expert consensus and outcomes/pathology data from follow-up imaging.

8. The Sample Size for the Training Set

• The document does not explicitly state the sample size for the training set. It mentions that Brainomix 360 e-ASPECTS uses "trained machine learning AI algorithms" and a "random forest machine learning technique," but details about the training data are not provided in this summary.

9. How the Ground Truth for the Training Set Was Established

• The document does not explicitly state how the ground truth for the training set was established. It only describes the ground truth for the testing/validation sets.

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